Senators Concerned About FDA Policy Changes for Personal Prescription Imports
Sens. Chuck Grassley, R-Iowa, and Amy Klobuchar, D-Minn., expressed concern to Food and Drug Administration Commissioner Scott Gottlieb that his agency is scaling back its “non-enforcement policy” currently allowing for limited personal importation of prescription drugs, Klobuchar’s office announced Dec. 26. The “non-enforcement policy” for patients with a valid prescription has been FDA’s position “for many years,” including its 2016 Regulatory Procedures Manual, the senators wrote in a recent letter to Gottlieb. “Thousands” of constituents have complained about “skyrocketing” prescription drug prices in the U.S., and the senators asked the Office of Management and Budget and the Department of Health and Human Services earlier this year to use statutory authority to allow personal imports of prescription drugs.
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Grassley and Klobuchar noted that the FDA reportedly sent criminal investigators with search warrants to nine Florida stores that help patients buy prescription drugs from Canadian pharmacies. “It is our understanding that these stores solely assist patients who prefer to purchase prescription drugs from outside the United States -- including by helping patients avoid websites that sell fraudulent or unsafe products -- and do not dispense drugs themselves,” the senators wrote. Grassley and Klobuchar also asked for the FDA’s support of the Safe and Affordable Drugs from Canada Act, introduced by Sen. John McCain, R-Ariz., in January 2017 (see 1701100036). Pending in the Senate Health Committee, the bill would amend the Federal Food, Drug, and Cosmetic Act to allow personal imports of safe and affordable drugs from approved Canadian pharmacies.